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A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

Primary Purpose

Burns, Burn Scar, Contracture

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Technology-assisted rehabilitation

Usual care

About this trial

This is an interventional prevention trial for Burns focused on measuring exercise, therapy, rehabilitation, home

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age greater than or equal to 18 years old (no upper age limit)
Ability to provide written, informed consent for study participation
Ability to read and understand English
Anticipated discharge to home environment
Home environment includes access to:
- television (larger than 20 inches in diameter with High Definition Multimedia Interface input (HDMI)
- internet and email address
- telephone (cell phone or landline)

Exclusion Criteria:

Age less than 18 years
Inability to provide written, informed consent for study participation
Inability to read or understand English
Delirium (as determined by the Delirium Observation Score test)
Near-fall event at time of screening
Pregnant women
Discharge to non-home environment (e.g., shelter, street, skilled nursing facility)

Sites / Locations

Harborview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

technology-assisted rehabilitation

Usual care

Arm Description

The experimental group will receive treatment as usual, in addition to training with the Jintronix platform. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

Outcomes

Primary Outcome Measures

Level of physical activity

level of activity among enrolled subjects by actigraphy

Secondary Outcome Measures

Range of motion (ROM)

ROM by subjects in each group

Patient-reported outcome measures (PROMIS): sleep

Sleep and sleep disturbance Short Form (SF)8B PROMIS tool

Patient-reported outcome measures (PROMIS): social participation

Participation in social roles and activities PROMIS tool SF6A

Patient-reported outcome measures (PROMIS): pain interference

Pain interference PROMIS tool SF6A

Patient-reported outcome measures (PROMIS): fatigue

Fatigue PROMIS tool SF6A

Patient-reported outcome measures (PROMIS): stiffness

Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0

Patient-reported outcome measures (PROMIS): mobility

Mobility PROMIS tool

Patient-reported outcome measures (PROMIS): upper extremity

Upper extremity PROMIS SF7A

Return to work/school

Date when subject returns to work or school

Patient reported level of activity difficulty

Using 1-5 difficulty scale (1=no difficulty and 5=very difficult), subject is asked how difficult his/her activity has been for the past 2 days

Full Information

NCT ID

NCT03475654

First Posted

March 1, 2018

Last Updated

November 5, 2020

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT03475654

Brief Title

A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

Official Title

Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

February 8, 2018 (Actual)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The overarching goal for this prospective randomized controlled trial (PRCT) is to determine whether a virtual-environment, home-rehabilitation program improves functional outcomes for individuals after a burn injury. Specifically, this study will test the efficacy of a technology-assisted rehabilitation program against current standard of home therapy.

Detailed Description

This is a prospective, randomized controlled trial (PRCT) involving 50 adult burn survivors. This study tests the efficacy of a technology-assisted rehabilitation program against current standard of home therapy. There are two study groups for which subjects will be randomized: control and experimental.The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. The experimental group receives treatment as usual, in addition to training and use of the Jintronix platform for 3 months after hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns, Burn Scar, Contracture

Keywords

exercise, therapy, rehabilitation, home

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective randomized controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

technology-assisted rehabilitation

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Technology-assisted rehabilitation

Intervention Description

The Jintronix software platform, coupled with the Microsoft Kinect for movement capture, contains individualized exercise modules to increase ROM, endurance and strength. Within this PRCT, online monitoring of activity and actigraphy measurements through a wearable device and completion of an online diary will provide enhanced monitoring of home activities.

Intervention Type

Behavioral

Intervention Name(s)

Usual care

Intervention Description

The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.

Primary Outcome Measure Information:

Title

Level of physical activity

Description

level of activity among enrolled subjects by actigraphy

Time Frame

3 months after study enrollment

Secondary Outcome Measure Information:

Title

Range of motion (ROM)

Description

ROM by subjects in each group

Time Frame

Study enrollment, 3, 6 and 12 months after enrollment

Title

Patient-reported outcome measures (PROMIS): sleep

Description

Sleep and sleep disturbance Short Form (SF)8B PROMIS tool

Time Frame